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AQUA-SEAL

by Respiratory Care, Inc.

510(k) K761202

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761202 Date9 Dec 1976ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KDQ
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AQUA-SEAL is a vacuum drainage bottle designed to re-establish negative pressure within the patient's pleural space to facilitate lung re-expansion following surgery or injury. It functions as a collection device for thoracic drainage, maintaining the necessary vacuum to support respiratory recovery.

The device is supplied by Respiratory Care, Inc. and is classified under product code KDQ as a collection vacuum bottle. It is intended for single use in clinical settings such as general hospitals. Storage conditions and specific handling instructions are not detailed in the available specifications.

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